This is a summary of the European public assessment report (EPAR) for Replagal. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Replagal.
Replagal : EPAR - Summary for the public (PDF/82.69 KB)
First published: 12/04/2007
Last updated: 29/07/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
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|Anatomical therapeutic chemical (ATC) code||
Takeda Pharmaceuticals International AG Ireland Branch
|Date of issue of marketing authorisation valid throughout the European Union||
Block 2 Miesian Plaza
20/09/2022 Replagal - EMEA/H/C/000369 - 0124/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Other alimentary tract and metabolism products
Replagal is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase-A deficiency).